Our services

An experienced medical writing consultancy providing high quality documents for the pharmaceutical, biotechnology and medical device industries.
CLINICAL TRIALS DOCUMENTATION

  • Protocols and informed consent forms
  • Clinical study reports
  • Patient narratives
  • Investigator brochures
  • Investigational medicinal product dossiers (IMPD)
  • Registry postings
  • Lay summaries
REGULATORY DOCUMENTS

  • Briefing packages
  • NDA/MAA/CTD clinical modules
  • Responses to EMA/FDA questions
  • Integrated summaries of safety & efficacy
  • PIP/PSP & waivers
  • Risk management plans
  • Orphan designation applications
  • Core value dossiers
MEDICAL COMMUNICATIONS

  • Publications
  • Literature reviews
  • Systematic reviews
  • Slides, posters & abstracts
  • Conference reports
  • Medical education materials
MEDICAL DEVICES

  • Clinical investigation plans
  • Clinical investigation reports
  • Clinical evaluation reports
  • Medical device publications

OUR EXPERTS

  • Highly qualified scientists (PhD or MD)
  • Native English (or equivalent)
  • International team located in France and the UK
  • Expertise in a wide range of document types and therapeutic areas
  • Expert writing and communication skills

QUALITY IS OUR TOP PRIORITY

  • Robust quality management system
  • Successful client audits
  • Full compliance with EMA, FDA and ICH guidelines
  • Systematic in-house document review and quality control
  • Excellent reputation in the industry
  • Preferred-provider for several customers
  • Many highly satisfied customers